Buagafuran Active Pharmaceutical Ingredient, Preparation Method and Application Thereof
申请人:BEI JING YUAN QI ZHI YAO TECHNOLOGY CO. LTD
公开号:US20190337913A1
公开(公告)日:2019-11-07
A method suitable for large-scale production of buagafuran active pharmaceutical ingredient. A buagafuran active pharmaceutical ingredient (API) with a high purity prepared by the method includes an active ingredient of buagafuran, an impurity A, and an impurity B. In the buagafuran API, a content of the active ingredient of buagafuran is higher than 97.5%, and a total content of the impurity A and the impurity B is less than 0.04%. The buagafuran API can be applied to new drug development processes such as clinical research, pharmaceutical research and quality control research.
一种适用于大规模生产布加氟兰活性药物成分的方法。通过该方法制备的高纯度布加氟兰活性药物成分(API)包括布加氟兰的活性成分、杂质A和杂质B。在布加氟兰API中,布加氟兰的活性成分含量高于97.5%,而杂质A和杂质B的总含量低于0.04%。布加氟兰API可应用于新药开发过程,如临床研究、药物研究和质量控制研究。